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510(k) Data Aggregation

    K Number
    K070987
    Device Name
    SENTINEL LITHIUM ASSAY
    Manufacturer
    SENTINEL CH SPA
    Date Cleared
    2007-08-02

    (118 days)

    Product Code
    NDW
    Regulation Number
    862.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SENTINEL CH SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A lithium test system is a device intended to measure lithium levels in serum or plasma. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). For use on Architect and Aeroset analyzers.
    Device Description
    The Multigent Lithium test is a spectrophotometric method, which can be readily adapted to automated clinical chemistry analyzers. Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change of absorbance, which is directly proportional to the concentration of lithium in the sample.
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